In recent years, the private and public sectors have increased investments in medical diagnostics for low- and middle-income countries (LMICs). Despite these investments, numerous barriers prevent the adoption of existing diagnostics and discourage the development and introduction of new diagnostics in LMICs. In the late 1990s, the global vaccine community had similar challenges, as vaccine coverage rates stagnated and the introduction of new vaccines was viewed as a distraction to delivering existing vaccines. To address these challenges, the international community came together and formed the Global Alliance for Vaccines Initiative (GAVI). Sixteen years after the formation of GAVI, we see evidence of a healthier global vaccine landscape. We discuss how GAVI’s four guiding principles (product, health systems strengthening, financing and market shaping) might apply to the advancement of medical diagnostics in LMICs. We present arguments for the international community and existing organizations to establish a Global Alliance for Medical Diagnostics Initiative (GAMDI).

Background: Diagnostics in many low- and middle-income countries are conducted through centralized laboratory networks. Samples are collected from patients at remote point-of-care health facilities, and diagnostic tests are performed at centralized laboratories. Sample transportation systems that deliver diagnostic samples and test results are crucial for timely diagnosis and treatment in such diagnostic networks. However, they often lack the timely and accurate data (eg, the quantity and location of samples prepared for collection) required for efficient operation. Objective: This study aims to demonstrate the feasibility, adoption, and accuracy of a distributed data collection system that leverages basic mobile phone technology to gather reports on the quantity and location of patient samples and test results prepared for delivery in the diagnostic network of Malawi. Methods: We designed a system that leverages unstructured supplementary service data (USSD) technology to enable health workers to submit daily reports describing the quantity of transportation-ready diagnostic samples and test results at specific health care facilities, free of charge with any mobile phone, and aggregate these data for sample transportation administrators. We then conducted a year-long field trial of this system in 51 health facilities serving 3 districts in Malawi. Between July 2019 and July 2020, the participants submitted daily reports containing the number of patient samples or test results designated for viral load, early infant diagnosis, and tuberculosis testing at each facility. We monitored daily participation and compared the submitted USSD reports with program data to assess system feasibility, adoption, and accuracy. Results: The participating facilities submitted 37,771 reports over the duration of the field trial. Daily facility participation increased from an average of 50% (26/51) in the first 2 weeks of the trial to approximately 80% (41/51) by the midpoint of the trial and remained at or above 80% (41/51) until the conclusion of the trial. On average, more than 80% of the reports submitted by a facility for a specific type of sample matched the actual number of patient samples collected from that facility by a courier. Conclusions: Our findings suggest that a USSD-based system is a feasible, adoptable, and accurate solution to the challenges of untimely, inaccurate, or incomplete data in diagnostic networks. Certain design characteristics of our system, such as the use of USSD, and implementation characteristics, such as the supportive role of the field team, were necessary to ensure high participation and accuracy rates without any explicit financial incentives.

Medical products used in the developed world often fail to adequately serve resource-limited settings where electricity, transportation and health care workers are not readily available. We suggest that the problem is not only a lack of coordinated financial resources to purchase existing medical products, but also a lack of products that are specifically designed for resource-limited settings. While donor organisations with a focus on global health are increasingly willing to bear the additional financial risk for the research and development of such high-impact medical products, corporations are still reluctant to take their best scientists and engineers away from more commercially attractive projects. Universities, on the other hand, given their teaching and research missions, are well positioned to engage in such high-risk development projects. A group of biomedical, engineering, business and social science researchers at Northwestern University (NU) propose a creative model to address significant social and health needs. The team's initial product focus is a rapid test for diagnosing infants with HIV. The NU model aligns the incentives and expertise of industry, donors and academia to innovate medical products, such as the infant HIV diagnostic test, for resource-limited settings.

In global settings, both the clinical use case and value proposition have been well articulated. This has led to the development of many point-of-care (POC) diagnostics for infectious diseases. However, in the United States, more than 80% of infectious disease diagnostics are performed in reference laboratories that have high throughput but relatively long turnaround times. As the cost of POC assays has decreased with nucleic acid test (NAT) innovation catalyzed by the coronavirus disease 2019 pandemic, we sought to develop clinical use cases for human immunodeficiency virus (HIV) NATs and the technical specifications that would tip the value proposition toward commercialization and meaningful adoption. Without POC HIV NATs, we are unlikely to achieve our collective goal of HIV elimination in the United States.

TheCenter for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) is a partner in the Point-of-Care Technologies Research Network (POCTRN) of the National Institutes of Biomedical Imaging and Bioengineering. POCTRN’s mission is to drivethe development of appropriate point-of-care (POC) diagnostic technologies through collaboration that merges scientific and technological capabilities with clinical need. C-THAN develops POC technologies for improved management of HIV/AIDS in low- and middle-income countries with a focus on sub-Saharan Africa. C-THAN incorporates clinical and user needs with technology expertise and resources to address commercialization and implementation barriers through: 1) assessment of unmet clinical needs in POC testing for HIV/AIDS and its comorbidities; 2) collaborations with physicians, researchers and engineers; 3) development of technical, clinical, industrial and regulatory partnerships; 4) clinical testing of prototype devices; and 5) creation of training opportunities for technology developers, evaluators, and other stakeholders. Technologies supported include tests for detection and monitoring of HIV/AIDS and its common comorbidities including tuberculosis, non-tuberculous mycobacteria, viral hepatitis and HIV-related malignancies. CTHAN relies on collaborations established by Northwestern University in Nigeria, South Africa, Mali and Tanzania, to have impact on the prevention and clinical management of HIV/AIDS.